Food Allergen Detection Methods and Systems Using Molecularly Imprinted Polymers

ABSTRACT

Methods and devices for the detection of food allergens using molecularly imprinted polymers that are imprinted for a target food allergen. A molecularly imprinted polymer may be imprinted using surface imprinting or other procedures. Detection of food allergens, such as peanut allergens, may be accomplished using all or a portion of a protein food allergen as a template to produce a molecularly imprinted polymer for food allergen detection. A portion utilized can be one that creates receptor sites in the molecularly imprinted polymer that are unique or more unique to the target food allergen than receptor sites that would be created if an entire food allergen molecule were utilized.

RELATED APPLICATION DATA

This application claims the benefit of priority of U.S. ProvisionalPatent Application Ser. No. 61/859,556, filed on Jul. 29, 2013, andtitled “Molecularly Imprinted Polymers for Detecting Allergens andPoint-of-Consumption Detection Device,” which is incorporated byreference herein in its entirety.

FIELD OF INVENTION

The present invention generally relates to the field of food allergendetection. In particular, the present invention is directed to foodallergen detection methods and systems using molecularly imprintedpolymers.

BACKGROUND

Many people suffer from allergies to foods of various types. While theseverity of allergic reactions varies, many reactions can be fatal.Preventing the inadvertent ingestion of and/or exposure to foodallergens is a concern for many. Present allergen-detection tools forassisting individuals with avoiding exposure generally requiresophisticated technology and expertise. These tools are also typicallytoo bulky for individuals to use at the point of consumption of food.

SUMMARY OF THE DISCLOSURE

In one implementation, a method for detecting a food allergen at thepoint of consumption of a food item by a first mammal is provided. Themethod includes exposing a first target item with a portable foodallergen detection platform at the point of consumption, the portablefood allergen detection platform including; a substrate; and amolecularly imprinted polymer layer in contact with the substrate, themolecularly imprinted polymer layer including a polymer imprinted on afirst surface of the polymer with receptor sites created by a firsttemplate, the receptor sites keyed to detect a first indicator of afirst food allergen; detecting the presence or absence of one or moremolecules of the first indicator bound to one or more of the receptorsites; and providing a visual indication of the presence of the firstfood allergen.

In another implementation, a method for detecting a food allergen at thepoint of consumption of a food item by a first mammal is provided. Themethod includes exposing a first target item with a portable foodallergen detection platform at the point of consumption, the portablefood allergen detection platform including: a substrate; and amolecularly imprinted polymer layer in contact with the substrate, themolecularly imprinted polymer layer including a polymer imprinted withreceptor sites created by a first template, the receptor sites keyed todetect a first indicator of a first food allergen; providing contact ofa color development agent with one or more molecules of the firstindicator bound to one or more of the receptor sites; detecting a colorchange in the color development agent to provide a visual indication ofthe presence of the first food allergen to the first mammal.

In yet another implementation, a method of manufacturing a food allergendetection device is provided. The method includes depositing a templateof a first food allergen on a first surface of a first substrate, thetemplate being a selected portion of a protein associated with the firstfood allergen, the selected portion including a segment of the proteinunique to the protein; depositing a pre-polymerization solution on asecond surface of a second substrate, the pre-polymerization solutionincluding a functional monomer and a crosslinking agent; contacting thefirst surface with the second surface to stamp the template onto thepre-polymerization solution; initiating polymerization of the templateand the pre-polymerization solution; and removing the template and anynon-polymerized portions of the pre-polymerization solution to form amolecularly imprinted polymer having receptor sites keyed for theselected portion of the protein.

In yet another implementation, a food allergen detection device fordetecting a food allergen at the point of consumption of a food item bya first mammal is provided. The device includes a holder; a portablefood allergen detection platform removably within the holder, theportable food allergen detection platform including: a substrate; and amolecularly imprinted polymer layer in contact with the substrate, themolecularly imprinted polymer layer including a polymer imprinted on afirst surface of the polymer with receptor sites created by a firsttemplate, the receptor sites keyed to detect a first indicator of afirst food allergen; and a color development agent, the colordevelopment agent selected and configured to provide a visual indicationof the presence of the first food allergen upon detecting a binding ofone or more molecules of the first indicator to one or more of thereceptor sites.

In still yet another implementation, a method for detecting a foodallergen, the method comprising: exposing a first target item with amolecularly imprinted polymer layer having a polymer imprinted withreceptor sites created by a first template, the receptor sites keyed toa first food allergen; detecting the presence or absence of the firstfood allergen in the first target item, the detecting includingobserving a visual indication or electrical signal indicating thepresence or absence of the food allergen.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of illustrating the invention, the drawings show aspectsof one or more embodiments of the invention. However, it should beunderstood that the present invention is not limited to the precisearrangements and instrumentalities shown in the drawings, wherein:

FIG. 1 illustrates one exemplary implementation of a food allergendetection device;

FIG. 2 illustrates one exemplary implementation of a generalized processof an MIP production;

FIG. 3 illustrates one exemplary implementation of a method of surfaceimprinting an MIP;

FIG. 4 illustrates another exemplary implementation of a food allergendetection device;

FIG. 5 illustrates yet another exemplary implementation of a foodallergen detection device; and

FIG. 6 illustrates an exemplary implementation of a method for detectinga food allergen using an MIP.

DETAILED DESCRIPTION

Molecularly imprinted polymers (MIPs) can be utilized in systems andmethods for detecting the presence of food allergens. Food allergensvary in form, chemical makeup, and location within substances consumedby humans. Example consumable substances that may include a foodallergen include, but are not limited to, an animal product, a grain(e.g., gluten), a vegetable, a fruit, a dairy product, a fish, abeverage, a legume (e.g., peanut), a chocolate, a synthetic foodchemical (e.g., monosodium glutamate (MSG), and any combinationsthereof. A consumable substance may include one or more food allergens.In one example, a food allergen may include a food protein. Due to theimportance of peanut allergies, a peanut-related food allergen is usedin an exemplary fashion in this disclosure. It is contemplated thatother food allergens may replace the discussed peanut-related foodallergen in the example, embodiment, implementation or other aspect ofthe disclosure. One way to test for the presence of a peanut-relatedfood allergen is to test for a peanut protein allergen. Examples of apeanut protein include, but are not limited to, arachis hypogaeaallergen 1 (ara h1), arachis hypogaea allergen 2 (ara h2), arachishypogaea allergen 3 (ara h3), and any combination thereof.

A food allergen may be present in any of a variety of items that may bea target for detecting a food allergen. For example, a food allergentarget item may be a food itself (or a portion thereof) or an item thatthe food has come into contact with (e.g., a serving utensil, a table,etc.). Food allergen target items may come in a variety of formsincluding, but not limited to, a solid, a liquid, a gas, a suspension,and any combinations thereof. Example solid food allergen target itemsinclude, but are not limited to, a solid food (e.g., a bread, a nut), aplate, a table, a utensil, and any combinations thereof. Example liquidfood allergen target items include, but are not limited to, a liquidfood, a beverage (e.g., a soda, milk, a juice), a food extract, and anycombinations thereof. Examples of a suspension food allergen target iteminclude, but are not limited to, an allergen suspended in air (e.g., afood allergen in particulate form), an allergen suspended in water, andany combinations thereof

Humans are used herein in an exemplary fashion when discussing foodallergens. It is intended that the embodiments, implementation, examplesand other aspects of the present disclosure apply to humans and othermammals.

FIG. 1 illustrates an exemplary implementation of a food allergendetection device 100. Food allergen detection device 100 includes amolecularly imprinted polymer (MIP) 105 that is coded/keyed to allow thebinding of a target food allergen (e.g., a peanut protein allergen) toMIP 105. Food allergen detection device 100 also includes a detectorelement 110 that is configured to detect the binding of the target foodallergen to allow the indication of the presence and/or absence of thetarget food allergen with respect to a target item.

A molecularly imprinted polymer, such as MIP 105 and other MIP'sdiscussed herein, may be produced by any of a variety of methods. FIG. 2illustrates one example of a generalized process of an MIP production.Host molecules 205 (functional monomers/polymers) are shown bound to atemplate 210. A template (e.g. template 210) is a molecule thatresembles closely a target food allergen (e.g., a molecule of the foodallergen itself, a portion of a molecule of the food allergen, etc.).Host molecules 205 are crosslinked 215 to form a polymer with template210 in place. Template 210 is then removed to form a molecularlyimprinted polymer having a cavity 220 that provides a receptor site forbinding of the target food allergen.

Example polymers include, but are not limited to, poly(4-vinylphenol)(PVP), poly(urethane) (PU), poly(methylmethacrylate) (PMMA),poly(methacrylic acid), and any combination thereof.

A template molecule may bind to a host molecule in a variety of ways.Example ways of binding a template molecule to a host molecule include,but are not limited to, a covalent binding, an ionic binding, a hydrogenbond binding, and any combinations thereof. Extraction of a template maybe done using any procedure that allows the specific template to beremoved while leaving the MIP having the cavity/receptor sites intact.Selection of a template removal procedure may include consideration ofthe strength of the binding of the template to the host molecule (e.g.,the stronger the binding, the more difficult the removal). The strengthof the binding of a host molecule and a template may also impactselection of the host molecule to allow for a desired level of bindingof the template to the host molecule for a given target food allergen.Example ways of extracting a template include, but are not limited to,chemical washing, water washing, and any combinations thereof.

A template for coding/keying an MIP may include one or more target foodallergen molecules. Multiple food allergens are discussed above. In onesuch example, a template is a food allergen molecule. In another suchexample, a template is a food protein molecule. In still another suchexample, a template is a peanut protein. In yet another such example, atemplate is an ara h1 peanut protein.

A template for coding/keying an MIP may also include only a portion ofone or more target food allergen molecules. A portion of a target foodallergen molecule may provide a more unique keying in the creation of amore specific receptor site in the MIP that is more unique to the targetfood allergen. In using an entire food allergen molecule (e.g., thecomponent of a food that causes an allergic reaction in a human) it ispossible that a cavity/receptor site created in an MIP may allow bindingof a molecule that is similar in shape, size, and/or bindingcharacteristics to a target food allergen but that is not the targetfood allergen. In such an example, food allergen detection may have thepotential for a false positive. In one exemplary aspect using a portionof a food allergen molecule, which is more unique to the target foodallergen (e.g., in binding characteristics to the host molecule), as atemplate may increase the specificity of the resulting MIP receptorsites for binding to the target food allergen. In one example, atemplate is a portion of a food allergen molecule. A portion utilizedmay be one that creates receptor sites in the molecularly imprintedpolymer that are unique or more unique (i.e., are more specificallykeyed) to the target food allergen than receptor sites that would becreated if an entire food allergen molecule were utilized. One exemplarybenefit of such increased targeting may be the minimization of falsepositives and/or false negatives in detecting a target food allergen. Inanother example, a template is a portion of a food protein molecule. Instill another example, a template is a portion of a peanut protein. Inyet another example, a template is a portion of an ara h1 peanutprotein. In still yet another example, a template is a protein epitope.In a further example, a template is a 14-peptide epitope (sequence:DLAFPGSGEQVEKL), for ara h1.

One example method of making an MIP includes using surface imprinting ofa template onto a polymer. A surface imprinted MIP includes surfacereceptor sites that larger target allergens, such as food proteins, canhave access to potentially more easily than internal cavities of apolymer matrix. In one example, a surface imprinted MIP is in the formof a thin film. Any of the implementations of a method of detecting afood allergen and/or devices for detecting a food allergen of thepresent disclosure may include a surface imprinted MIP. FIG. 3illustrates one example of a method of surface imprinting an MIP. Atstep 305, a template is deposited on a surface of a first substrate.Example templates are discussed above. In one example, a monomericprotein template is utilized for a target allergen that exists innature, at least in some instances, as a trimeric protein. In one suchexample, an ara h1 protein may exist in nature as a trimer and a monomerof the protein may be used as a template. In another example, a templateis a 14-peptide epitope (sequence: DLAFPGSGEQVEKL), for ara h1. Acoating may be applied to the first substrate. In one example, apoly(dimethylsiloxane) (PDMS) coating is applied to the first substrateand the template is applied thereto. In one such example, PDMS issolubilized and spin coated on the surface of the first substrate.

At step 310, a pre-polymerization solution is deposited on a surface ofa second substrate. Example substrates include, but are not limited to,a quartz, a glass, alumina, mica, silicon, a III-IV semiconductorcompound, a plastic, a paper, and any combinations thereof. A substratemay have a variety of properties. Example properties of a substrateinclude, but are not limited to, inclusion of a rigid material,inclusion of a flexible material, being a monolithic structure, being amultilayer structure, being a composite structure, and any combinationsthereof. In one example, a substrate includes a flexible material. Inanother example, a substrate includes a rigid material. In anotherexample, a substrate is a multilayer or other composite structure havingconstituents of different properties and compositions. A substrate mayalso include one or more additional electronic elements integrated intothe substrate. Example additional electronic elements include, but arenot limited to, a thermistor, an integrated circuit element, and anycombinations thereof. A pre-polymerization solution includes thecomponents for building the MIP with the template. Example componentsfor a pre-polymerization solution include, but are not limited to, afunctional host molecule (e.g., a functional monomer, a functionalpolymer), a crosslinking agent, a solvent, a polymerization initiator,and any combinations thereof. A functional host molecule is a molecule(such as host molecule 205) used to build the polymer of an MIP. Examplepolymers for a surface imprinted MIP include, but are not limited to,poly(4-vinylphenol) (PVP), poly(urethane) (PU), poly(methylmethacrylate)(PMMA), poly(methacrylic acid), and any combination thereof. In oneexample, a pre-polymerization solution includes a functional hostmolecule and a crosslinking agent. In another example, apre-polymerization solution includes a functional host molecule, acrosslinking agent, a solvent, and a polymerization initiator. Ratios ofcomponents in a pre-polymerization solution are such that polymerizationof the components and the binding of the template can occur. In oneexample, a ratio of crosslinking agent to functional host is about 1:1to about 10:1. In another example, a ratio of crosslinking agent tofunctional host is 1:1 to 10:1. In yet another example, a ratio ofcrosslinking agent to functional host is about 1:1. In still anotherexample, a ratio of crosslinking agent to functional host is 1:1. Instill yet another example, a ratio of crosslinking agent to functionalhost is about 2:1. In a further example, a ratio of crosslinking agentto functional host is 2:1.

At step 315, the surfaces of the first and second substrates having thetemplate and the pre-polymerization solution are contacted to stamp thetemplate to the pre-polymerization solution. At step 320, polymerizationis initiated. Example ways to initiate polymerization include, but arenot limited to, a photochemical initiation, an application of heat, acatalyst, and any combinations thereof. In one example, polymerizationis initiated by the application of light.

At step 325, after the polymerization is complete, the template andnon-polymerized portions of the pre-polymerization solution (e.g.,remaining non-polymerized host molecules, crosslinking agent, solvent,polymerization initiator) are removed. Example ways to remove a templateare discussed above. In one example, a template and non-polymerizedportions of a pre-polymerization solution are washed for removal. Aftera template and non-polymerized portions of a pre-polymerization solutionare removed, the resulting MIP can be utilized to detect the selectedtarget food allergen.

In another example of a method of surface imprinting an MIP, a foodallergen protein template stamp is produced using glass slides assubstrates. The glass slides are cleaned in a piranha solution, rinsedwith water, and stored under inert atmosphere. The protein template selfassembles on a PDMS coating that is spin coated onto a surface of one ofthe glass slides to produce the protein template stamp. A degassedpre-polymerization gel-point solution including a functional monomer, acrosslinking agent, a solvent, and a polymerization initiator isdeposited on a surface of a second of the glass slides. The proteintemplate stamp is pressed onto the pre-polymerization solution.Polymerization is initiated photochemically and/or thermally. After thepolymerization is complete, the first glass slide is removed and thesecond glass slide is washed repeatedly to remove the protein andnon-polymerized portions of the pre-polymerization solution. Removal ofa template can be confirmed by analysis of a wash solution using uv/visspectroscopy. After washing, the resulting MIP is ready to be utilizedfor detection of a target food allergen protein.

Other surface imprinting methods for making an MIP for food allergendetection may also be utilized. Additionally, alternative methods tosurface imprinting may be utilized to make an MIP for detection of afood allergen in any of the methods and devices disclosed herein. Onealternative example includes using a hydrogel process for producing ahydrogel MIP. In one such example, a functional host, a template, apolymerization initiator, and a crosslinking agent are directly mixed.In one example, the ratio of functional host to crosslinking agent is1:1. Example polymer hosts for a hydrogel implementation include, butare not limited to poly(hydroxyethylmethacrylate) (PHEMA),poly(vinylpyrrolidone) (PVP), and any combination thereof.

Other example methods for making an MIP that are alternatives to thesurface imprinting discussed above include examples where the templateand host molecules are mixed together to form a polymer matrix. In onesuch example, an MIP film is produced using a phase inversion-spincoating onto a suitable substrate. Examples of wet phase inversionprocedures can be found in Wang, et al. (1997) Langmuir 13:5396;Shibata, et al. (1999) J. Appl. Poly. Sci. 75:1546; Trotta, et al.(2002) J. Membr. Sci. 201:77, Crabb, et al. (2002) J. Appl. Polym. Sci.86:3611; Richter, et al. (2006), J. Appl. Polym. Sci. 101:2919; Campell,et al. (2009) Surface and Interface Analysis 41:347), each of which isincorporated herein by reference for the methods of production of MIPdisclosed therein. In one such example, host molecules are dissolvedwith a template in a theta solvent. A template-host network is allowedto form in solution and precipitated by immersion in a non-solvent. In aspecific example, a thin film MIP having a PVP polymer can be producedby mixing PVP host molecules in a conventional casting solution with atemplate in a suitable solvent (e.g., methanol, dimethylformamide (DMF),etc.). The solution is allowed to mix at room temperature (e.g., fromsix to 24 hours) to form a hydrogen-bonded network in solution.Subsequently, thin films are cast onto a substrate using a spin coater(e.g., at 5000-7000 rpms for about 30 seconds). The thin film is allowedto dry and the template molecule is removed by washing (e.g., withwater).

An MIP may be in the form of a thin film. A thin film may be of avariety of thicknesses. In one example, a thin film MIP has a thicknessof about 300 nanometers (nm) to about 5 micrometers. In another example,a thin film MIP has a thickness of 300 nm to 5 micrometers.

Returning to FIG. 1, MIP 105 may be included in device 100 as part of afood allergen detection platform. A food allergen detection platform mayinclude a substrate and an MIP layer. Examples of a substrate include,but are not limited to, a glass, a plastic, a paper, a polymer, and anycombinations thereof. In one example, a food allergen detection platformis in the form of a test strip. As discussed above, an MIP may be formedon a substrate (e.g., via surface imprinting, stamping). In anotherexample, an MIP may be applied to a substrate after it is formed (e.g.,via spin coating or other application technique). An MIP layer may be ofany thickness that allows for the desired detection of a target foodallergen. The MIP layer may be of a variety of forms. Example forms foran MIP layer include, but are not limited to a thin film, a membrane, ananowire, micromonolith, and any combinations thereof. In one example,an MIP layer is a thin film.

Detector 110 may include any detector capable of determining thepresence and/or absence of a target food allergen that binds to one ormore of the receptor sites of MIP 105. Detection of a presence of atarget food allergen may include detection of an amount of a target foodallergen that is present. Detection may also include determination ofbinary indication that the target food allergen is present or notpresent. Detection of a presence and/or absence of a target foodallergen may include the detection of the food allergen itself or anindicator of the presence of the food allergen. In one example, anindicator of the presence of the food allergen may be a molecule orportion of a molecule of a target food allergen. A detector may beincluded in a food allergen detection device in a variety of ways.Example ways of inclusion include, but are not limited to, as acomponent of a food allergen detection platform, as a component of anMIP, as a component separate from a food allergen detection platform, asa component separate from an MIP, and any combinations thereof.

A variety of detectors can be used. In one example, a detector thatprovides a visual indication of the presence of food allergen bound toone or more receptor sites is utilized. In one such example, a detectorincludes a color development agent. A color development agent is anagent that changes color in the presence of a target food allergen boundto one or more of the receptor sites of an MIP. Example colordevelopment agents include, but are not limited to, Coomassie BrilliantBlue (CBB). In one example, a color development agent is CoomassieBrilliant Blue. A visual indicator may have different degrees of visualindication depending on the quantitative amount of a target foodallergen that is bound to one or more receptor sites of an MIP.Different degrees of visual indication may provide a user of a detectiondevice (such as device 100) with an ability to discern the level of afood allergen present. In one such example, a color development agentcan have different colors (and/or different degrees of color) based onthe amount of a target food allergen bound to one or more receptor sitesof an MIP. In another example, a visual indicator is configured toprovide a visual indication when the amount of a target food allergenbound to one or more receptor sites of an MIP reaches a level that iscapable of eliciting an allergic reaction in an allergy sufferer. Theamount of a food allergen that can cause an allergic reaction differsfrom one target food allergen to another and example amounts for aspecified target food allergen can be readily determined.

A target food allergen may bind to a receptor site of an MIP in avariety of ways. Example ways of binding a food allergen to a receptorsite of an MIP include, but are not limited to, a covalent binding, anionic binding, a hydrogen bond binding, and any combinations thereof.

In one example, a detector (such as detector 110) is a separatecomponent to an MIP. In one such example, a detector is brought intocontact with an MIP after an MIP is exposed to a target item. Thedetector then can detect the presence of any target food allergen boundto one or more receptor sites of the MIP. In another such example, adetector is a color development agent and the color development agent iscapable of being applied to an MIP of a food allergen detection platformafter the MIP is exposed to a target item. The color development agentchanges color based on the presence or absence of target food allergenbound to one or more of the receptor sites of the MIP.

In another example, a detector (such as detector 110) is directlyassociated with an MIP. In one such example, a detector is a componentof a food allergen detection platform having an MIP. A directlyassociated detector can detect the presence of a target food allergenbound to one or more receptor sites of an MIP without having to bringthe detector into contact with the MIP after the MIP is exposed to atarget item. In one example using a color development agent, the colordevelopment agent may be a component of a food allergen detectionplatform along with an MIP. The color development agent has a directchange in color when a target food allergen is bound to one or more ofthe receptors of the MIP.

Alternative detectors to a visual indicator detector are alsocontemplated for use with an MIP of the current disclosure. Examplealternative detectors include, but are not limited to, an electricalcharacteristic detector (e.g., a conductive detector, a capacitivedetector). Combinations of such examples with a visual detector are alsocontemplated. An electrical characteristic detector is a detector thatcan determine changes in an electrical characteristic of an MIP based onthe presence or absence of a target food allergen bound to one or morereceptor sites of the MIP. Example electrical characteristics that canprovide a basis for detecting the presence or absence of a targetallergen include, but are not limited to, electrical resistance,electrical conductance, current, voltage, capacitance, transistor oncurrent, transistor off current, transistor threshold voltage, and anycombinations thereof. In an alternative example, a basis for detectingthe presence or absence of a target food allergen may include acombination of properties, relationships between different properties,and/or a variation of one or more properties over time.

Capacitive detectors are well-known in the art and any suitable detectorcan be employed with an MIP of the current disclosure. In one example, acapacitive detector element can include a sandwich-type electrodeconfiguration (e.g., with an MIP placed between two capacitor elementsor electrodes). Any suitable conductor or semiconductor material can beused as an electrode. Example conductor/semiconductor materials include,but are not limited to, gold, platinum, silver, and any combinationsthereof. In another example, an interdigitated capacitor device iscombined with an MIP as part of a food allergen detection platform. Theinterdigitated capacitor device detects changes in capacitance of theMIP due to bound target food allergen. In one such example, a set ofinterdigitated electrodes with an MIP of the present disclosure coatedonto the electrode assembly. In a specific example, a sandwich-typecapacitive sensor is produced by depositing chromium on a glass,silicon, or mica substrate by thermal evaporation. The chromium ispatterned by photolithography and treated, subsequently, by wet etching.An insulating silicon dioxide layer (e.g., with a thickness between 40nm and 200 nm) is deposited onto the bottom electrode surface using anelectron-gun thermal deposition technique. Subsequently, the MIP layeris spun coated on the substrate surface. A Cr film (e.g., with athickness of 70 nm) is deposited on the MIP film surface by thermalevaporation, followed with patterning by photolighography and wetetching.

Any conductive detector can be used that will detect the presence and/orabsence of a target food allergen. In one example, a conductive polymeris utilized with a template as a doping agent. In such an example, thepresence or absence of a template molecule influences the conductivityof the polymer. Example conductive polymers include, but are not limitedto, a it electron-conjugated conductive polymer, a polyaniline, apolyaniline derivative, a polypyrrole, a polypryrrole derivative, apolythiophene, a polythiophene derivative, a copolymer of two or more ofthe same, and any combinations thereof. In another example, achemiresistor is combined with an MIP as part of a food allergendetection platform to detect changes in conductivity of an MIP due tothe presence of a target food allergen bound to one or more receptorsites of the MIP. In one such example, a detection device (such asdevice 100) includes an electronic readout device connected to theinterdigitated capacitor device and/or the chemiresistor for providing auser of the detection device with information regarding the change incapacitance/conductivity and/or information about thepresence/quantitative amount of the target food allergen (e.g., via acomparison of data stored in a memory regarding a relation between thechange in capacitance/conductivity and the presence/amount of the targetfood allergen).

A detector based on electrical characteristics may include and/or beassociated with a power source. A power source can be electricallyconnected to a detector, a substrate, and/or an MIP for providing powerto allow for detection of a target food allergen. In one example, apower source is included as a component of a food allergen detectionplatform. In another example, a power source is included in a detectiondevice as a separate component to the food allergen detection platform.Examples of a power source include, but are not limited to, a battery, asolar cell, a fuel cell (e.g., a miniature and portable fuel cell), athermocouple, a radio-frequency energy source, an electrochemical energysource, a supercapacitor, an energy scavenging device, and anycombinations thereof. A power source may be used to power othercomponents of a food allergen detection device.

A food allergen detection device (such as device 100) may include anelectronic processing element (e.g., a microprocessor) for processinginformation and data related to the presence and/or absence of a targetfood allergen (e.g., where a detector of a food allergen detectiondevice includes an electrical characteristic detector).

A food allergen detection device (such as device 100) may also include amemory element for storing information and data for assisting aprocessing element with determining the presence and/or absence of atarget food allergen. Example memory elements include, but are notlimited to, a magnetic disk (e.g., a conventional floppy disk, a harddrive disk), an optical disk (e.g., a compact disk “CD”, such as areadable, writeable, and/or re-writable CD; a digital video disk “DVD”,such as a readable, writeable, and/or rewritable DVD), a magneto-opticaldisk, a read-only memory “ROM” device, a random access memory “RAM”device, a magnetic card, an optical card, a solid-state memory device(e.g., a flash memory), an EPROM, an EEPROM, and any combinationsthereof. A memory may be included in a food allergen detection device asa part of a processing element, as a separate component to a processingelement (e.g., with an electrical connection to the processing element),or both. In one example, a memory and a processing element are part of afood allergen detection platform. In another example, a memory and aprocessing element are a separate component of a food allergen detectiondevice from a food allergen detection platform. A processing element maybe electrically connected to a power supply, a memory element, adetector, an MIP (e.g., a substrate or other electrical characteristicportion of an MIP), another component of a food allergen detectiondevice, and any combinations thereof. A memory may include anyinformation and data that may be utilized by a processing element indetermining a presence and/or absence of a food allergen. Exampleinformation includes, but is not limited to, information on an MIPmaterial, information on an MIP layer thickness, information of aconductive detector element material, information of a conductivedetector element thickness, information of a capacitive detector elementmaterial, information of a capacitive detector element thickness,information of an electrical characteristic detector, information of atarget food allergen (e.g., resistance, conductive, capacitiveproperties of a target food allergen), machine readable instructions fordetermining a presence and/or absence of a target food allergen, machinereadable instructions for executing any one or more of the embodimentsand/or implementations described in the current disclosure, and anycombinations thereof.

A food allergen detection device (e.g., device 100) may also include auser input element. A user input element is an electronic and/ormechanical component allowing a user to provide an input to a foodallergen detection device (e.g., providing an input to a processingelement of a food allergen detection device). A user input element maybe electrically and/or mechanically connected to a component of a foodallergen detection device. In one example, a user input element iselectrically and/or mechanically connected to a processing element of afood allergen detection device. Examples of an input element include,but are not limited to, a button, a toggle, an alpha-numeric inputdevice (e.g., a keyboard), a pointing device, a joystick, an audio inputdevice (e.g., a microphone, a voice response system, etc.), a cursorcontrol device (e.g., a mouse), a touchpad, a video capture device(e.g., a still camera, a video camera), touch screen, and anycombinations thereof. Example uses for an input element include, but arenot limited to, allowing a user to start a process of detecting thepresence or absence of a food allergen, allowing a user to stop aprocess of detecting the presence or absence of a food allergen, and anycombinations thereof.

A food allergen detection device (e.g., device 100) may also include anoutput element. An output element is an electronic, chemical, and/ormechanical component providing an indication of a result of a detectingby a food allergen detection device of a presence and/or absence of afood allergen. An output element may, in some examples, indicate anamount of a food allergen present (e.g., a quantitative value of foodallergen present). An output element may be electrically and/ormechanically connected to components of a food allergen detectiondevice. In one example, an output element is electrically connected to aprocessing element of a food allergen detection device. Examples of anoutput element include, but are not limited to, a display element (e.g.,an LCD screen, an LED screen), a chemical change visual indicator, alight element (e.g., a LED light indicating a presence or absence of afood allergen), and any combinations thereof.

FIG. 4 illustrates another implementation of a food allergen detectiondevice 400. Food allergen detection device includes components for whichexemplary aspects and features are discussed throughout the currentdisclosure (e.g., with respect to device 100 of FIG. 1). Except asindicated these exemplary aspects and features may be applied tocomponents of device 400. Device 400 includes an MIP 405 and a detector410. Device 400 also includes a processing element 415 connected todetector 410 (e.g., for processing data and information related to thepresence or absence of a target food allergen bound to MIP 405).Processing element 415 may also be connected to MIP 405 (e.g., where MIP405 includes as a component thereof detector 410 or a portion ofdetector 410). Device 400 also includes a memory 420 (connected toprocessor 415), a user input element 425 (connected to processor 415),and an output element 430 (connected to processor 415). Processor 415may be configured to control input element 425 and output element 430(e.g., using machine executable instructions and/or other informationstored in memory 420. Device 400 also includes a power supply 435connected to processing element 415, memory 420, user input 425, outputelement 430, and detector 410. Power supply 435 may also be connected toother components that may require power (e.g., user input 425 if userinput 425 includes an electrical component). In other examples, powersupply 435 may be connected to fewer components (e.g., where a componentdoes not require power, such as a detector that is a chemical visualindicator detector.

A food allergen detection device may include one or more MIPs that areimprinted (i.e., have receptor sites) to two or more target allergens.In one example, an MIP is imprinted for two or more target allergens. Inanother example, a food allergen detection device includes a pluralityof MIP's with at least two of the MIPs imprinted for different targetallergens. In one such example, the plurality of MIP's are in an array.One or more MIP's that are imprinted to two or more target allergens maybe a component of a food allergen detection platform as discussedherein. An MIP imprinted for a food allergen, a food allergen detectionplatform having an MIP imprinted for a food allergen, and/or a detectormay be removable from a detection device. In one such aspect, adetection device includes a holder in which an MIP, a food allergendetection platform, and/or a detector may be removed from the holder.

FIG. 5 illustrates one example of a food allergen detection device 500including an MIP 505 that is removable from device 500 (e.g., from aholder of device 500). MIP 500 is shown as being removed from device500. MIP 505 may be a part of a food allergen detection platform that isremovable from device 500. MIP 505 is shown as being contactable with afood related target item 515. Device 500 includes a detector 510 fordetecting the presence of a target food allergen bound to one or more ofthe receptor sites of MIP 505. Example detectors and aspects thereof arediscussed above and are applicable to device 500. In one example, MIP505 is reinserted to device 500 after exposure to target item 515 andbrought into contact with detector 510 to allow detector 510 to detect atarget food allergen bound to one or more receptor sites of MIP 505. Inone such example, MIP 505 (as part of a food allergen detection platformthat is in a form of a dipstick/test stick) is insertable into anopening in device 500 exposing MIP 505 to detector 510 (e.g., a colordevelopment agent in liquid form). In another example, detector 510 isalso removable from device 500 and is configured to be contactable withMIP 505 after exposure to target item 515 to allow detector 510 todetect a target food allergen bound to one or more receptor sites of MIP505. In one such example, detector 510 includes a color developmentagent that can be applied to MIP 505 externally to device 500. In stillanother example, detector 510 and MIP 505 are both components of a foodallergen detection platform that is removable from device 500 such thatafter MIP 505 is exposed to target item 515, detector 510 is already incontact with MIP 505 to detect a target food allergen bound to one ormore receptor sites of MIP 505. Food allergen detection device 500 mayalso include one or more other components of a detection device asdisclosed herein (e.g., with respect to device 100 and/or device 400).

A food allergen detection device according to any of theimplementations, embodiments, and/or examples described herein may beportable. A food allergen detection device according to any of theimplementations, embodiments, and/or examples described herein may bedesigned and configured for use at the point of consumption of a fooditem by a user. Example aspects discussed herein that may, in certainexamples, assist in the use at a point of consumption include, but arenot limited to, a portability of a device, a wearability of a device, aremoveability of an MIP from a device, other aspects and configurationsdescribed herein, and any combinations thereof.

A food allergen detection device according to any of the implementationsdescribed herein may be integrated into an article wearable by a human.Example articles wearable by a human include, but are not limited to, ajewelry article, a badge, and any combinations thereof. In one example,an article wearable by a human is an article of jewelry. Examplearticles of jewelry include, but are not limited to, a necklace, abracelet, an amulet, a locket, and any combinations thereof.

A food allergen detection device according to any of the implementationdescribed herein (e.g., a portable device, a wearable device, etc.) mayinclude a visual symbol element of the target food allergen for whichthe device is configured to detect. For example, a visual symbol elementfor a device that targets peanut allergens can be a visual symbolelement depicting a peanut, a visual symbol element for a device thattargets milk and/or other dairy allergens can be a visual symbol elementdepicting a cow, a visual symbol element for a device that targets eggallergens can be a visual symbol element depicting an egg, a visualsymbol element for a device that targets gluten and/or wheat allergenscan be a visual symbol element depicting a sheaf of wheat, etc. Examplevisual symbol element forms include, but are not limited to, a charmaffixed to a device, an etching in a surface of a device, the shape of adevice or a portion of a device itself, another structural visualdepiction of a target food allergen, and any combinations thereof. Adevice may include multiple visual symbol elements (e.g., where thedevice targets more than one food allergen). A visual symbol element maybe removable. In one exemplary aspect, a visual symbol element of atarget food allergen may be helpful for individuals in recognizing thetype of allergen an individual is sensitive to, such as when theindividual cannot explain the allergy themselves. For example, awaitress may recognize that a patron is allergic to peanuts upon seeinga peanut charm on a device worn by the patron. The waitress may deterthe individual from eating certain dishes and/or provide appropriateaction if the patron is having an allergic reaction.

A food allergen detection device may include an anti-allergen component.Example anti-allergen components include, but are not limited to, anEpi-Pen (e.g., a small sized Epi-Pen), epinephrine, an antihistamine,and any combinations thereof. An anti-allergen component may beintegrated directly into the device. In another example, ananti-allergen component is associated with the device (e.g., as a kit).An anti-allergen component may also be removable. In one exemplaryaspect, an anti-allergen component is configured to allow a user of thedevice to apply the anti-allergen component to an individual having anallergic reaction (e.g., an allergic reaction to an allergen detected bythe device) and/or an individual as a precautionary measure based ondetecting the presence of an allergen detected by the device. Exemplaryforms for an anti-allergen component for administration to an individualinclude, but are not limited to, a pill form, an injection form, aliquid form, and any combinations thereof.

Benefits that may be part of a food allergen detection device of one ormore of the implementations described herein include, but are notlimited to, a high sensitivity to detecting certain food allergens, ahigh selectivity of detecting certain food allergens (e.g., using aportion of a food allergen to surface imprint an MIP), portable andsmall form, ease of use by a consumer (e.g., devices lacking electronicsmay not require power, devices with electronic detectors requiringminimal power suitable for battery operation), mobility, wearability,long shelf-life (e.g., water insoluble polymers can provide long shelflives), low cost, ability to use at the point of consumption of anallergen-containing substance, and any combinations thereof.

FIG. 6 illustrates an exemplary method 600 for detecting a food allergenusing an MIP of the current disclosure. At step 605, a target item isexposed to an MIP encoded to detect a target food allergen. The MIP maybe a component of a food allergen detection platform. Aspects andfeatures of an MIP and a food allergen detection platform are discussedabove. Some of the aspects and features are discussed in detail againwith respect to method 600, but other aspects and features are alsoapplicable to method 600 as appropriate. In one example, a food allergendetection platform includes a substrate and an MIP layer that includes apolymer imprinted with receptor sites created by a template. An MIP maybe surface imprinted. A food allergen detection platform may alsoinclude a visual indicator (e.g., a color development agent). In anotherexample, an MIP may be associated with an electrical characteristicdetector. Exposing a target item to an MIP may occur in a variety ofways. Example ways to expose a target item to an MIP include, but arenot limited to, direct contact of an MIP to a target item, applying atarget item (e.g., a sample of a target item) to an MIP (e.g., via aliquid dropper, via an applicator configured to transfer a solid orsemisolid target item to an MIP, etc.), removal of an MIP from a holderof an allergen detection device to put the MIP in contact with a targetitem, removal of an MIP from a holder of an allergen detection device toapply a target item to the MIP, and any combinations thereof.

At step 610, the presence or absence of a target food allergen isdetected. Detection of the presence or absence of a target food allergenmay occur in a variety of ways. In one exemplary aspect, detection ofthe presence or absence of a target food allergen may be performed bydetecting the presence or absence of one or more molecules of anindicator of the food allergen being bound to one or more receptor sitesof the MIP. An MIP may be a component of an food allergen detectionplatform as discussed herein. Detection may include determining anamount of the food allergen present (e.g., not just determining thepresence or lack of presence). In another example, the mere presence orabsence may be detected without determining an amount.

Example ways to detect the presence or absence of a target food allergeninclude, but are not limited to, detecting an electrical characteristicof an MIP or a material associated with the MIP (e.g., a substrate),detecting a chemical interaction that produces a color change in thepresence of a target food allergen, detecting a lack of a chemicalinteraction that produces a color change in the absence of a target foodallergen, detecting presence or absence of a target food allergen usinganother visual-type indicator, and any combinations thereof. The variousfeatures, embodiments, implementation, and examples of detectors andtheir processes discussed above are applicable here to the detection ofthe presence or absence of a target food allergen. For example,detecting an electrical characteristic may include detecting electricalresistance, electrical conductance, current, voltage, capacitance,transistor on current, transistor off current, and/or transistorthreshold voltage. Example electrical characteristic detector elementsand their features are described in detail above. Detection of anelectrical characteristic may occur via detection of a signal (e.g.,using a processing element or other circuitry, examples of which aredescribed above).

In one example of detecting a visual indication (e.g., a color change orlack thereof), a color development agent is applied to an MIP to producea detectable color change in the presence of a target food allergen.Exemplary ways of application of a color development agent (or otherchemical additive that produces a visual change or other detectableevent) include, but are not limited to, applying a liquid agent to anMIP (e.g., using a liquid dropper device), having an agent be in contactwith an MIP (e.g., as a component of a food allergen detection platform,as an integral component of an MIP) prior to the exposing step 605,bringing an agent into contact with an MIP outside of a holder of a foodallergen detection device, bringing an agent into contact with an MIPinternally to a holder of a food allergen detection device, and anycombinations thereof. Examples of color development agents and theirfeatures are discussed above.

Method 600 may include a step (not shown) of rinsing an MIP (e.g., byrinsing a food allergen detection platform having an MIP). In oneexample, a rinsing step occurs after the exposing step 605 and prior to(or at about the same time as) detecting step 610. One potential benefitto rinsing may be to remove materials that are not bound to a receptorsite. Such materials may interfere with the detecting step (e.g.,provide false positive measurements, impact quantitative measurement,etc.).

At step 615, a result indication of the presence of the target foodallergen is provided to a user. In one example, the indication isgenerated by a visual indicator detector that performs the detecting ofthe binding and the indication to the user. In one such example, avisual indicator is a color development agent. The provision of a resultindication of the presence of a target food allergen may occur as acomponent of the detecting step 610. For example, when a visualindicator detector is used the detection may involve a color change in achemical agent, the color change providing a visual indication to theuser. In another example, an electronic display or other output devicemay be utilized to provide information and/or data related to thedetection (e.g., an electronic indication of the presence or absence, aquantitative indication, etc.).

Exemplary embodiments have been disclosed above and illustrated in theaccompanying drawings. It will be understood by those skilled in the artthat various changes, omissions and additions may be made to that whichis specifically disclosed herein without departing from the spirit andscope of the present invention.

1. A method for detecting a food allergen at the point of consumption ofa food item by a first mammal, the method comprising: exposing a firsttarget item with a portable food allergen detection platform at thepoint of consumption, the portable food allergen detection platformincluding: a substrate; and a molecularly imprinted polymer layer incontact with the substrate, the molecularly imprinted polymer layerincluding a polymer imprinted on a first surface of the polymer withreceptor sites created by a first template, the receptor sites keyed todetect a peanut food protein; detecting the presence or absence of oneor more molecules of the peanut food protein bound to one or more of thereceptor sites; and providing a visual indication of the presence of thepeanut food protein.
 2. A method according to claim 1, wherein thedetecting the presence or absence of one or more molecules includes:applying a color development agent to the portable food allergendetection platform after said exposing a first target item; anddetecting a color change in the color development agent, said providingthe first mammal with a visual indication including providing visualaccess of the detected color change to the first mammal.
 3. A methodaccording to claim 2, further comprising rinsing the portable foodallergen detection platform after said exposing a first target item andbefore said applying a color development agent.
 4. A method according toclaim 1, wherein the detecting the presence or absence of one or moremolecules includes detecting the presence or absence of a color change.5. A method according to claim 4, wherein the color change is due to thecontact of a color development agent with the molecularly imprintedpolymer layer.
 6. A method according to claim 1, wherein the portablefood allergen detection platform further comprises a color developmentagent, the color development agent selected and configured to providethe visual indication of the presence of the peanut food protein uponsaid detecting the binding of one or more molecules.
 7. A methodaccording to claim 1, wherein the detecting the presence or absence ofone or more molecules includes detecting an electrical characteristic ofthe molecularly imprinted polymer layer and/or the substrate.
 8. Amethod according to claim 7, wherein the electrical characteristic is anelectrical characteristic selected from the group consisting of anelectrical resistance, an electrical conductance, a current, a voltage,a capacitance, a transistor on current, a transistor off current, atransistor threshold voltage, and any combinations thereof.
 9. A methodaccording to claim 7, wherein the providing a visual indication includesproviding a display with information related to the presence or absenceof the food allergen.
 10. A method according to claim 1, wherein thefirst template is a portion of a molecule of the peanut food protein,the portion of the molecule being unique to indicate the peanut foodprotein.
 11. (canceled)
 12. (canceled)
 13. A method according to claim1, wherein the first template is an epitope of the peanut food protein.14. A method according to claim 1, wherein the first template is a14-peptide epitope, DLAFPGSGEQVEKL, for arachis hypogaea allergen 1 (arah1).
 15. (canceled)
 16. (canceled)
 17. A method according to claim 1,wherein the polymer includes a polymer selected from the groupconsisting of: a poly(4-vinylphenol), a poly(urethane), apoly(methylmethacrylate), a poly(methacrylic acid),poly(hydroxyethylmethacrylate), poly(vinylpyrrolidone), and anycombinations thereof.
 18. (canceled)
 19. (canceled)
 20. A methodaccording to claim 1, wherein the peanut food protein includes a proteinselected from the group consisting of: arachis hypogaea allergen 1 (arah1), arachis hypogaea allergen 2 (ara h2), arachis hypogaea allergen 3(ara h3), and any combination thereof.
 21. A method according to claim1, wherein the substrate includes a substrate selected from the groupconsisting of: a glass, a plastic, a paper, a quartz, alumina, mica,silicon, a III-IV semiconductor compound, and any combinations thereof.22. A method for detecting a food allergen at the point of consumptionof a food item by a first mammal, the method comprising: exposing afirst target item with a portable food allergen detection platform atthe point of consumption, the portable food allergen detection platformincluding: a substrate; and a molecularly imprinted polymer layer incontact with the substrate, the molecularly imprinted polymer layerincluding a polymer imprinted with receptor sites created by a firsttemplate, the receptor sites keyed to detect a peanut food protein;providing contact of a color development agent with one or moremolecules of the peanut food protein bound to one or more of thereceptor sites; detecting a color change in the color development agentto provide a visual indication of the presence of the peanut foodprotein to the first mammal.
 23. (canceled)
 24. (canceled) 25.(canceled)
 26. A method according to claim 22, wherein the firsttemplate is a portion of a molecule of the peanut food protein, theportion of the molecule being unique to indicate the peanut foodprotein.
 27. (canceled)
 28. (canceled)
 29. A method according to claim22, wherein the first template is an epitope of the peanut food protein.30. (canceled)
 31. (canceled)
 32. (canceled)
 33. (canceled) 34.(canceled)
 35. (canceled)
 36. A method according to claim 22, whereinthe peanut food protein includes a protein selected from the groupconsisting of: arachis hypogaea allergen 1 (ara h1), arachis hypogaeaallergen 2 (ara h2), arachis hypogaea allergen 3 (ara h3), and anycombination thereof. 37.-79. (canceled)
 80. A system for detecting afood allergen at the point of consumption of a food item by a firstmammal, the system comprising: means for exposing a first target itemwith a portable food allergen detection platform at the point ofconsumption, the portable food allergen detection platform including: asubstrate; and a molecularly imprinted polymer layer in contact with thesubstrate, the molecularly imprinted polymer layer including a polymerimprinted with receptor sites created by a first template, the receptorsites keyed to detect a peanut food protein selected from the groupconsisting of: arachis hypogaea allergen 1 (ara h1), arachis hypogaeaallergen 2 (ara h2), arachis hypogaea allergen 3 (ara h3), and anycombination thereof; means for providing contact of a color developmentagent with one or more molecules of the peanut food protein bound to oneor more of the receptor sites; means for detecting a color change in thecolor development agent to provide a visual indication of the presenceof the peanut food protein to the first mammal.